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Trial record 27 of 225 for:    "essential thrombocythemia"

Exploratory Phase II Study of INC424 Patients With Primary Myelofibrosis (PMF) or Post Polycythaemia Myelofibrosis (PPV MF) or Post Essential Thrombocythaemia Myelofibrosis (PET-MF) (MACS2030)

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ClinicalTrials.gov Identifier: NCT01558739
Recruitment Status : Completed
First Posted : March 20, 2012
Results First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Primary Myelofibrosis (PMF)
Post Polycythaemia Myelofibrosis (PPV MF)
Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
Intervention: Drug: INC424

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
54 patients were screened. 48 patients were enrolled as planned.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
INC424 Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.

Participant Flow:   Overall Study
    INC424
STARTED   48 
COMPLETED   31 
NOT COMPLETED   17 
Adverse Event                7 
Withdrawal by Subject                2 
Death                3 
Disease Progression                4 
Protocol Violation                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled patients were included in the Full Analysis Set and the Safety Set.

Reporting Groups
  Description
INC424 Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.

Baseline Measures
   INC424 
Overall Participants Analyzed 
[Units: Participants]
 48 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.12  (10.419) 
Gender 
[Units: Participants]
 
Female   21 
Male   27 


  Outcome Measures

1.  Primary:   Percentage of Participants With Treatment Success   [ Time Frame: 48 Weeks ]

2.  Secondary:   Percentage of Participants With Best Overall Response   [ Time Frame: week 48 ]

3.  Secondary:   Change From Baseline in Myelofibrosis Symptoms Assessment Form (MF-SAF)   [ Time Frame: Baseline, week 4, week 12, week 24, week 48 ]

4.  Secondary:   Change From Baseline in EQ5D Preference Index (5 Level EuroQol Questionnaire Determining Quality of Life) From Baseline   [ Time Frame: Baseline, week 4, week 12, week 24, week 48 ]

5.  Secondary:   Number of Hospitalizations   [ Time Frame: week 12, week 24, week 26, week 48 ]

6.  Secondary:   Duration of Hospitalizations   [ Time Frame: week 48 ]

7.  Secondary:   Number of Accident & Emergency Visits From Baseline   [ Time Frame: baseline to week 12, week 12 to week 24, week 24 to week 36, week 36 to week 48 ]

8.  Secondary:   Number of General Practitioner (GP), Specialists' and Urgent Care Visits   [ Time Frame: baseline to week 12, week 12 to, week 24, week 24 to week 36, week 36 to week 48 ]

9.  Secondary:   Percentage of Participants With Transfusion Dependency Status   [ Time Frame: baseline (BL), end of treatment (up to 28 days post last treatment) (EOT) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01558739     History of Changes
Other Study ID Numbers: CINC424AGB02
2011-005066-38 ( EudraCT Number )
First Submitted: March 16, 2012
First Posted: March 20, 2012
Results First Submitted: January 26, 2015
Results First Posted: March 3, 2015
Last Update Posted: March 3, 2015